Apparatus, system, and method for applying and adjusting a tensioning element to a hollow body organ

Abstract

An adjustable support pad for adjustably holding a tensioning line used to apply tension to a body organ. The adjustable support pad can include a locking mechanism for preventing slidable movement of the tensioning element in one or both directions. The locking mechanism may include spring-loaded locks, rotatable cam-like structures, and/or rotatable spool structures. The adjustable support pad may be formed from rigid, semi-rigid, and/or flexible materials, and may be formed to conform to the outer surface of a body organ. The adjustable support pad can be configured to adjustably hold one or more separate tensioning lines, and to provide for independent adjustment of one or more tensioning lines or groups thereof.

1. A method for replacing a chordae tendon in a heart, the heart having an apex, a native valve leaflet, a ventricle, and a heart wall, the method comprising:
 providing a replacement chordae tendinae assembly, the assembly comprising: (a) a tensioning line having a first end portion and a second end portion, wherein the first end portion is configured for attachment to a native valve leaflet; and (b) an adjustable support pad configured for attachment to a heart wall, the adjustable support pad comprising a first surface configured to be placed against and secured to the heart wall, the adjustable support pad configured to receive the tensioning line therethrough and including a locking mechanism configured to slidingly receive the tensioning line in a first direction with respect to the adjustable support pad, and to prevent the tensioning line from sliding in a second direction with respect to the adjustable support pad, wherein the first direction is opposite to the second direction; 
 passing the tensioning line into the ventricle by passing the tensioning line through the heart wall adjacent the ventricle; 
 securing the first end portion of the tensioning line to the native valve leaflet; 
 sliding the second end portion of the tensioning line through the adjustable support pad; 
 securing the adjustable support pad to the heart wall at a lower portion of the ventricle of the heart; 
 adjusting the length of the portion of the tensioning line which extends from the adjustable support pad to the native valve leaflet; and 
 locking the locking mechanism onto the tensioning line to prevent the tensioning line from further sliding through the adjustable support pad. 
 
     
     
       2. The method of  claim 1 , wherein the adjustable support pad is configured for attachment to an external surface of the heart wall, and wherein securing the adjustable support pad to the heart wall comprises securing the adjustable support pad to an exterior surface of the heart wall at a position adjacent the apex of the heart. 
     
     
       3. The method of  claim 1 , wherein the adjustable support pad comprises a plurality of suture openings therethrough, wherein the plurality of suture openings are positioned at or adjacent a perimeter of the adjustable support pad, and wherein securing the adjustable support pad to the heart wall comprises suturing the adjustable support pad to the heart wall using sutures passing through one or more of the plurality of suture openings. 
     
     
       4. The method of  claim 1 , wherein the locking mechanism has an unlocked configuration wherein the tensioning line can slidingly move in the first direction, and a locked configuration wherein the tensioning line is prevented from moving in the second direction, wherein adjusting the length of the portion of the tensioning line which extends from the adjustable support pad to the native valve leaflet comprises slidingly moving the tensioning line in the first direction. 
     
     
       5. The method of  claim 4 , wherein the locking mechanism in the unlocked configuration allows movement of the tensioning line in the second direction, and wherein adjusting the length of the portion of the tensioning line which extends from the adjustable support pad to the native valve leaflet comprises moving slidingly the tensioning line in the second direction. 
     
     
       6. The method of  claim 4 , wherein the locking mechanism in the locked configuration prevents movement of the tensioning line in the first direction, and wherein locking the locking mechanism onto the tensioning line comprises moving the locking mechanism from an unlocked configuration to a locked configuration. 
     
     
       7. The method of  claim 1 , wherein the tensioning line comprises a shock absorbing component. 
     
     
       8. The method of  claim 7 , wherein the shock absorbing component comprises a spring. 
     
     
       9. The method of  claim 1 , wherein the adjustable support pad comprises a pre-formed pad hole configured to receive the tensioning line therethrough, and wherein sliding the second end portion of the tensioning line through the adjustable support pad comprises sliding a portion of the tensioning line through the pre-formed pad hole. 
     
     
       10. The method of  claim 1 , wherein the adjustable support pad comprises a generally compressible and solid material configured to receive a suturing needle and suturing line therethrough, and wherein securing the adjustable support pad to the heart wall comprises suturing the adjustable support pad to the heart wall using the suturing needle to pass the suture line through the generally compressible and solid material. 
     
     
       11. A method of replacing a chordae tendon in a heart, comprising:
 securing a first portion of a replacement chordae tendon to a heart valve leaflet; 
 securing an adjustable support pad to an exterior surface of a heart wall of the heart; 
 passing the replacement chordae tendon through the heart wall; 
 adjusting tension in the replacement chordae tendon from outside the heart wall by proximally or distally moving a second portion of the replacement chordae tendon; and 
 securing the second portion of the replacement chordae tendon to the support pad. 
 
     
     
       12. The method of  claim 11 , further comprising:
 monitoring blood flow function of the heart valve while the heart is beating while concurrently adjusting tension in the replacement chordae tendon. 
 
     
     
       13. The method of  claim 12 , wherein monitoring the blood flow function of the heart valve comprises monitoring the function of the heart valve using an imaging system. 
     
     
       14. The method of  claim 11 , wherein securing the support pad to the exterior surface of the heart wall of the heart comprises securing the support pad adjacent the apex of the heart. 
     
     
       15. The method of  claim 11 , wherein securing the first portion of the replacement chordae tendon to the heart valve leaflet occurs prior to securing the second portion of the replacement chordae tendon to the support pad. 
     
     
       16. The method of  claim 11 , wherein adjusting tension in the replacement chordae tendon from outside the heart wall comprises adjusting tension while the heart is beating. 
     
     
       17. A method for replacing a chordae tendon in a heart having a native valve leaflet, a ventricle, and a heart wall, the method comprising:
 providing an the apparatus comprising: (a) a tensioning line; (b) an adjustable support pad comprising a first surface configured to be secured to a heart wall, the adjustable support pad further comprising an adjustable tensioning element configured to move with respect to the adjustable support pad, the adjustable support pad configured to receive and movably hold a portion of the tensioning line via movement of the adjustable tensioning element; and (c) a controller for controlling movement of the adjustable tensioning element; 
 passing the tensioning line into the ventricle by passing the tensioning line through the heart wall adjacent the ventricle; 
 securing a first end portion of the tensioning line to the native valve leaflet; 
 sliding a second end portion of the tensioning line through the adjustable support pad; 
 securing the first surface of the adjustable support pad to the heart wall at a lower portion of the ventricle of the heart; and 
 selectively adjusting tension in the tensioning line by selectively moving the adjustable tensioning element to control sliding movement of the second end portion of the adjustable tensioning line through the adjustable support pad. 
 
     
     
       18. The method of  claim 17 , wherein the controller comprises a motor, and wherein the step of selectively adjusting tension in the tensioning line by selectively moving the adjustable tensioning element comprises activating the motor to initiate movement of the adjustable tensioning element. 
     
     
       19. The method of  claim 18 , wherein the motor is positioned on or in the adjustable support pad. 
     
     
       20. The method of  claim 17 , wherein the adjustable tensioning element is configured for rotational movement, and wherein the step of selectively adjusting tension in the tensioning line by selectively moving the adjustable tensioning element comprises selectively rotating the tensioning element.